Sealing valve, in particular used in the catheter technique

ABSTRACT

The invention concerns a sealing valve which comprises a valve body (1) on which a sealing cylinder (8) is mounted. The sealing cylinder (8) contains a sealing stopper against which a pressure piston (18) abuts. A lever arm (23), which is loaded in terms of force by a spring component (31), presses on the pressure piston (18). The valve can be used within the scope of the interventional catheter technique for sealing a guide catheter. Advantageously it can be sensitively and topically actuated with one hand in an ergonomic manner.

The invention relates to a sealing valve with a longitudinally extendedvalve body that exhibits a connective end and a sealing end, in whichvalve body a valve passageway is embodied that extends from theconnection end to the sealing end in an axial direction, in which asealing plug that may be compressed for the purpose of sealing isprovided that is equipped with an axial plug passageway.

Such a sealing valve is known from the European patent document EP 0 267584. The valve body of the known sealing valve exhibits a main tube thatconstitutes the connection end, onto which a sealing cylinder thatconstitutes the sealing end is set. The internal diameter of the sealingcylinder is greater than the internal diameter of the main tube. Thetransition from the inner chamber of the sealing cylinder to thepassageway of the main tube is accomplished by means of a conicallytapering shoulder section. Within the inner chamber of the sealingcylinder, an elastic sealing plug is found that abuts the conicalshoulder section, which plug may be compressed with the aid of a plungerthat may be moved in the axial direction, but is secured againstrotations within the interior chamber of the sealing cylinder. Theplunger is equipped, on the side facing the sealing end, with a spiralsurface upon which an additional spiral surface of a lever closure thatis imposed upon the sealing cylinder presses. In order to activate thevalve, the lever closure is turned toward the sealing cylinder so thatthe spiral surfaces are shifted toward one another, and the plunger ismoved in the axial direction. If the sealing plunger is compressed, theelastic material of the sealing ring moves out of the way toward theinside, and the plug passageway is reduced in size. By virtue of thisfact, the sealing plug is able to seal off the sealing valve, or aninstrument that is guided through the sealing valve.

Such a sealing valve is a crucial component of interventional cathetertechnique. This technique is used, for example, to expand narrowedcoronary arteries with the aid of a balloon catheter. In order to bringthe balloon catheter to that point of the coronary arteries that must betreated, a guide catheter must, first of all, be introduced through anopening in the patient's inguinal area, and advanced, via the aorta, tothe origin of the artery to be treated. Thereafter, a wire having adiameter of a few tenths of a millimeter is introduced through thisguide catheter into the blood vessel that is to be treated. Then, theballoon catheter is threaded onto this wire and advanced to the point tobe expanded.

During these treatment steps, the guide catheter is sealed off by meansof the sealing valve. When the instruments are introduced, the left handof the physician rendering treatment holds the sealing valve while theright hand undertakes the movements that are necessary to maneuver theinstruments, either opening or closing the valve as necessary in theinterim. Because of the ungainly reaching around with the right handthat is necessary to activate the valve, the valve frequently remainsunintentionally and unnecessarily opened, for which reason, among otherthings, the patient loses considerable amounts of blood. In certaincircumstances, this state of affairs represents a threat to the patient.In any case, the field of instrumentation is soiled by considerableamounts of blood.

Furthermore, from the United States patent document U.S. Pat. No.4,917,668, a sealing valve is known that is comprised of a sealing body.The sealing body exhibits a connection piece that may be connected to aguide catheter, to which, in the axial direction, an introduction pieceis connected. The connection piece and the introduction piece areequipped, in each case, with a central passageway which may be sealedoff by means of an elastic sealing membrane, provided, in the area ofthe passageway, with slits, and clamped between the connection piece andthe introduction piece. On the side of the sealing membrane that facestoward the connecting catheter, the sealing membrane is supported by aspring element provided in the connection piece that assures the closureof the sealing membrane if no object that must be sealed is locatedwithin the passageway. On the side of the sealing membrane that facesaway from the catheter to be connected, there is a tappet with a centralpassageway, which tappet is mobile in the axial direction, toward thesealing membrane and is held, in the at rest position, by an additionalspring element at some distance from the sealing membrane. To open thesealing valve, a guide tube is pushed into the introducing portion,which tube pushes the tappet through the sealing membrane. A cathetermay then be advanced through the sealing membrane that is opened in thismanner and through the passageways of the sealing body into the guidecatheter that is applied to the connecting portion of the sealing body.

A check valve for medical purposes that exhibits a cup-like valvehousing is known from the European patent document EP 0 135 140. Aspiral spring is applied at the bottom of the cup that presses a valveslide against a sealing stop that is provided in the area of the openingof the cup. The slide, whose position may be shifted in an axialdirection within the valve housing, with its circumferential surface, isguided over a valve opening that is provided in the wall of the valvehousing, which leads to a channel groove that is introduced to theoutside of the valve housing, which groove runs in an axial direction.To open the valve, the slide is pushed in the direction of the bottom ofthe cup until the slide uncovers the valve opening in the wall of thevalve housing and the fluid that is to be sealed off can flow from theopening of the cup of the valve housing through the valve opening andthe channel groove into a catheter that surrounds the valve housing.

Taking this state of the art as a point of departure, it is theunderlying task of the invention to create a sealing valve that can beactivated with one hand in an ergonomic manner in a sensitive and timelyway.

This task is resolved by virtue of the fact that in order to compressthe sealing plug, a spring element is provided that may be neutralizedin its effect by means of an activation mechanism.

By virtue of the fact that the force for the compression of the sealingplug is applied by a spring element, the sealing valve can be opened andclosed quickly. In addition, it is assured that the sealing valve closesautomatically when the activation mechanism is released.

In the case of one preferred embodiment, a lever arm that runslongitudinally relative to the valve body, and is swivel-mounted on thevalve body with a pressure fork that is applied to the lever arm at aright angle, presses upon a pressure piston that abuts the sealing plugthat engages the passageway of the valve body. The elastic force isapplied by means of a spring element that is stretched between the leverarm and the valve body.

This sealing valve can be held, in relaxed fashion, with one hand, inmost cases, the left hand. In the process, the index finger, the middlefinger, and the ring finger lie on the lever arm and press the sealingvalve against the thumb that lies against the opposite side of the valvebody. By pressing the index, middle, and ring finger on one side, andthe thumb on the other side together, the valve can be activated in anergonomic fashion by means of a single movement with one hand.

Due to the fact that this sealing valve is a disposable article that isproduced in great quantities, the space required for its storage is acritical consideration. In the case of this sealing valve, the lever armis provided longitudinally, relative to the body of the valve. In thisway, the required storage volume is small, even in the case of a leverarm of great length.

However, with a great length of the lever, it is possible to achieve therequisite sensitivity during opening and closing.

In what follows, advantageous embodiments of the invention will bedescribed by virtue of the drawing.

FIG. 1 shows a view, in longitudinal section, of a sealing valve, inclosed state;

FIG. 2 shows a view, in longitudinal section, of the sealing valve, inthe opened state;

FIG. 3 shows a view from the back of the sealing valve from FIGS. 1 and2, in the closed state;

FIG. 4 shows a view, in longitudinal section, of an additionalembodiment of the sealing valve, in the closed state;

FIG. 5 shows a longitudinal sectional view of the sealing valve fromFIG. 4, in the opened state;

FIG. 6 shows a cross-section through the lever arm, along the line ofintersection VI--VI in FIG. 4;

FIG. 7 shows a further embodiment of the sealing valve;

FIG. 8 shows a cross-section through the arm of the lever along the lineof intersection VIII--VIII in FIG. 7;

FIG. 9 shows a longitudinal frontal view through the sealing valve fromFIG. 7, in the opened state;

FIG. 10 shows a cross-section through the arm of the lever, along theline of intersection X--X in FIG. 9;

FIG. 11 shows a view from the rear, of the sealing valve from FIG. 9;and

FIG. 12 shows an additional, derived embodiment example of the sealingvalve.

FIG. 1 shows a cross-sectional view of the sealing valve that exhibits avalve body 1 with a sealing end 2 and a connecting end 3. The valve body1 has at its disposal a main tube 4 with an axial passageway, 5. Asealing cylinder, 8, with an inner chamber 9, is positioned onto themain tube, 4, by way of a conical expansion, 6, with a conical interiorsurface, 7. At the connective end, 3, the main tube, 4, is slanted inconical fashion in order to render connection to a guide catheterpossible. In addition, at connective end 3, a threaded sleeve, 10, isfound, which may be screwed onto external threading of the guidingcatheter by way of internal threading, 11. A seal that is indicated inthe drawing by means of an annular groove 12 and an annular spring, 13,assures a tight connection of the sealing valve with the guidingcatheter. At a distance from connective end 3, laterally with respect tothe main tube 4, at an acute angle to the main tube, 4, a lateral tube14, is positioned, that may be connected, by way of a flange, 15, forexample, to a pressure measurement device. An elastic sealing plug 16abuts the conical inner surface 7 of the conical extension 6, which plughas the form of a cylinder with a superimposed cone. An axialpassageway, 17, through the plug, is embodied within the sealing plug16. In the closed position that is depicted in FIG. 1, the sealing plug16 is compressed by a compression piston, 18, and plug passageway 17 isclosed. Like the sealing plug, 16, compression piston 18 also has at itsdisposal an axial piston passageway, 19. On compression piston 18,toward the outside, a pressure plate, 20, that constitutes a stop isembodied against the sealing cylinder, 8. A pressure fork, 21, with benttines, 22, presses upon the pressure plate, 20. The pressure fork, 21,is set at right angles with respect to a lever arm, 23, that is arrangedlaterally in the longitudinal direction with reference to the main tube,4. If lever arm 23 moves, the tines, 22, of the pressure fork 21 rolloff on pressure plate 20. A helical compression spring, 24, is stretchedbetween the lever arm, 23, and the main tube, 4. For the sake ofclarity, the helical compression spring, 24, is not depicted incross-section, but rather, in a lateral view. The lever arm, 23, ismounted on a bearing above a hinged joint 25 that is provided in thearea of sealing end 2 so that it is capable of being swiveled. Thehelical compression spring, 24, presses the lever arm, 23, away from themain tube 4, and thus, the tines, 22, of the pressure fork, 21 pressupon the pressure plate, 20 of the compression piston, 18, whichcompresses the sealing plug, 16. The material of the elastic sealingplug, 16, led by the conical inner surface, 7 swerves toward the inside,thus closing the passageway through the plug, 17. An instrument that isled through the passageway through the plug, 17, is thus sealed off inthis way.

FIG. 2 shows the sealing valve from FIG. 1, in the opened state. Thehelical compression spring, 24, is compressed, and the end of the leverarm, 23, is arrested with the aid of a snap hook, 26. The snap hook, 26,that is applied to the main tube, 4, exhibits a bending taper, 27. As aresult of this bending taper, 27, the snap hook, 26, may be retracted,and the lever arm, 23, can be released from the stop. Thus, byactivating lever arm 23, the effects of helical compression spring 24can be neutralized.

It should be noted that in the case of a derived embodiment example thatis not depicted in the drawing, the snap hook, 26, is embodied so as tohave two or more stages. Such an embodiment of the snap hook, 26,enables the user to open or close the valve by stages.

FIG. 3 shows a view of sealing end 2 of the sealing valve. One canclearly distinguish the pressure plate 20 with the central pistonpassageway, 19. In addition, the tines, 22, of pressure fork, 21, whichabut pressure plate 20 on either side of the piston passageway 19, arediscernible. Between the tines, 22, of pressure fork, 21, a hingedjoint, 25, may be seen. Two articulated struts, 28, applied to thecompression cylinder 8, hold an articulated pin, 29. An articulatedgrommet, 30, that is applied to the lever arm, 23, engages between thearticulated struts, 28, which grommet is mounted on a bearing on thearticulated pin, 29, in such a way as to be capable of being swiveled.The helical compression spring, 24, may be discerned behind thearticulated hinge, 25.

In order to support the lever arm, 23, laterally, in the case of aderived embodiment example that is not depicted in the drawing, thearticulated struts, 28, and the articulated grommet, 30, are extended inthe longitudinal direction, so that ridge-shaped articulated struts forma groove into which a ridge-shaped articulated grommet engages.

The sealing valve that is depicted in FIGS. 1 through 3 is applied,above all, within the context of interventional catheter technique. Forexample, in order to expand constrictions of the coronary arteries withthe aid of a balloon catheter, the balloon catheter must be brought tothe site of the coronary arteries. To do so, a stable guide catheterhaving a relatively large lumen of up to ten French (=three millimeters)is introduced through an opening in the region of the patient's groin,by way of the aorta to the opening of the coronary artery that is to betreated. The guide catheter is sealed off by means of the sealing valveaccording to the invention. After that, a thin guide wire of one French(=one-third of a millimeter) in diameter is introduced through thesealing valve and the guide catheter, far into the coronary artery to betreated. By way of this wire, then, the balloon catheter, which servesto effect the actual treatment, is threaded on and advanced to the pointof expansion. During the entire treatment, the guide catheter is sealedoff from the high blood pressure in the aorta (150 mm on a mercurycolumn, which is approximately equal to 0.2 bar) by means of a sealingvalve according to the invention.

It should be noted that guidance catheters having a lumen of up to 14French (=4.2 millimeters) in diameter are used in radiology to expandblood vessels. Even these types of guidance catheters can be sealedusing the sealing valve according to the invention.

During treatment, the treating physician's left hand holds the sealingvalve while the right hand completes the movements necessary to maneuverthe instruments. The sealing valve can be operated in a particularlyergonometric fashion if the sealing valve is held between the thumb inone instance, and the index, middle, and ring finger in the other.Gripped in this way, only the index, middle, and ring fingers need to bebent slightly in order to hold the sealing valve. To close the sealingvalve, the index, middle, and ring finger are pressed against the thumbin a single motion. Due to the fact that only a single motion of thehand is needed to activate the valve, it is possible to work in arelaxed manner.

In addition, the sealing valve can be operated in timely fashion. Inundertaking treatment, for psychological reasons, the physicianproviding the treatment frequently has the impression that theinstrument that is advanced into the vessel undergoing treatment isblocked by the seal of sealing valve, whereas, in reality, by contrast,the inhibiting friction is produced at a point in the patient's body.With a sealing valve that can be opened and closed quickly, thephysician who is providing treatment can quickly ascertain the cause ofthe friction by opening the sealing valve slightly for a short time. If,by so doing, the resistance that inhibits the movement of the instrumentdoes not decrease, the point that is causing the resistance is locatedwithin the body of the patient. The physician can verify this fact allthe more readily if the sealing valve can be activated with a singlehand, so that the time-consuming switching of hands from the instrumentthat must be maneuvered to the sealing valve is unnecessary.

A further advantage is that the sealing valve is closed in the at-reststate. Thus, the physician who is providing treatment can, if he needs apause to rest, simply release the sealing valve without having toundertake additional maneuvers to close the sealing valve.

The sealing valve is, to good advantage, embodied as a disposableobject. Accordingly, the majority of the structural elements of thesealing valve consist of plastic. If it is necessary for the transfer offorce, in addition to the helical compression spring, 24, otherstructural elements, such as the lever arm, 23, or the tines, 22, of thepressure fork, 21, are made of a metallic material.

Due to the fact that the pressure valve is produced in large numbers ofunits as a disposable article, it is advantageous if little space isrequired for purposes of storage. In the case of the sealing valveaccording to the invention, the lever arm 23 is provided alongside maintube 4. Consequently, even a long lever arm, 23, does not appreciablyincrease the volume needed for storage.

A long lever arm is necessary, however, in order to achieve therequisite sensitivity in activating the valve.

A series of derivations of the sealing valve according to the inventionis conceivable.

FIG. 4 shows a sealing valve in which the helical compression spring,24, is replaced by a leaf spring, 31. The leaf spring, 31, is attachedto one end, in the area of sealing cylinder 8 on valve body 1, whereasthe other end of the leaf spring, 31, glides within a guide groove, 32,that is embodied in the lever arm, 23.

FIG. 5 shows the embodiment example from FIG. 4 in the opened state. Onecan see that the lever arm, 23, as in the case of the embodiment exampledescribed by virtue of FIGS. 1 through 3, may be arrested by a snaphook, 26.

For purposes of greater clarity, FIG. 6 shows a cross-section throughthe lever arm 23 along the line VI--VI in FIG. 4. One recognizes theleaf spring, 31, which glides within guide groove 32. Above all, guidegroove, 32 serves to prevent lateral movements of the lever arm, 23. If,as a result of this measure, sufficient lateral stability cannot beachieved, the guidance of the lever arm, 23, can be improved by virtueof the fact that the articulated struts, 28, as mentioned above, as wellas the articulated grommet, 30, are extended in the longitudinaldirection of the valve body 1, so that the lever arm, 23, is guidedbetter laterally.

FIG. 7 shows an additional embodiment example of the invention. In thecase of this embodiment example, at the end of the leaf spring, 31, thatis turned toward the lever arm 23, a protruding ridge, 33, is embodied.The ridge, 33, glides within guide groove 32, which makes thetransition, toward the end of the lever, to a rest depression, 34, thatis introduced into lever arm 23. From the opposite side of the lever arm23, a tappet, 35, engages rest depression 34 through tappet recess 36.The tappet, 35, may be activated by means of a release button, 37.

FIG. 8 shows a cross-section along the line VIII--VIII in FIG. 7.

FIG. 9 shows the embodiment example that is depicted in FIG. 7, with thesealing valve in its opened state. In this state, ridge 33 engages restdepression, 34, of the lever arm, 23. The tappet, 35, is pressed out ofrest depression 34 and cocks the release button, 37, of the pressedlever arm, 23. By activating the release button, 37, it is possible topush the tappet, 35, into the rest depression 34, thus releasing thearresting of lever arm 23.

The release button, 37, is, to good purpose, produced from a bladespring so that the release button, 37, in the opened state of thesealing valve, can be activated with the expenditure of little energy.

In the case of a derived embodiment example, two or more restdepressions, 34, are embodied in lever arm 23, so that the sealing valvemay be opened or closed in two or more steps.

For purposes of clarification, FIG. 10 shows a cross-section through thelever arm 23 along the line X--X in FIG. 9.

In the interest of completeness, FIG. 11 shows a view of sealing side 2of the embodiment example shown in FIGS. 7 through 10. The blade spring,31, and the release button, 37, may be seen distinctly.

Finally, FIG. 12 shows a cross-section view of an additional embodimentexample, in which a spiral spring, 38, serves as the spring element.This spiral spring, 38, exhibits a lever arm, 23, leg, 39, and a valvebody leg, 40, applied to valve body 1, as well as windings, 41, thatsurround the articulated pin, 29. The articulated pin, 29, is held bytwo articulated struts, 42, applied to sealing cylinder 8 on the side ofspiral spring 38. Two articulated grommets, 43, that are attached tolever arm 23, are mounted onto the articulated pin, 29, so as to swivel,to the side of the spiral spring, 38. As in the case of the embodimentexample depicted in FIGS. 1 through 3, the lever arm, 23, may bearrested by means of a snap hook, 26.

Finally, it should be noted that in addition to the derivations of thespring mechanism, additional derivations, especially of valve body 1,are possible. It is possible, for example, to position the sealingcylinder 8 immediately next to the main tube 4, without the conicalextension, 6, so that a contact surface for a sealing plug, whichsurface runs oblique to the longitudinal axis, results. This embodimentform has the advantage of greater simplicity.

An additional possibility is to use a sealing cylinder that exhibits thesame internal diameter as that of the main tube, 4. In the case of suchan embodiment example, a sealing plug can be held by a ring-shapedadhesive point in the sealing cylinder. Another possibility is toprovide, on a sealing plug, a ridge that runs in the direction of thecircumference that engages a groove that runs around the circumferenceof the inside of sealing cylinder 8. In this case, however, the side ofthe sealing plug that is exposed to the fluid that is to be sealed offmay not be selected so as to be too large, because otherwise, the springelement must apply a counteractive pressure of too great a strength.

I claim:
 1. A sealing valve for use with catheters, said valvecomprising:A valve body, said body including a connecting end and asealing end and a passage interconnecting said connecting end and saidsealing end; a movable sealing plug disposed in said passage for sealingsaid passage, said sealing plug including a plug passage; a compressingelement operably associated with said sealing plug; a spring for urgingsaid compressing element against said sealing plug and for moving saidplug into sealing engagement with said passage; and a neutralizingelement for preventing said spring from urging said compressing elementfrom moving said plug into sealing engagement with said passage.
 2. Thesealing valve according to claim 1 wherein said body comprises a hollowtubular body and a hollow sealing cylinder, said plug disposed in saidsealing cylinder, the inside diameter of said sealing cylinder beinggreater than the inside diameter of said tubular body.
 3. The sealingvalve according to claim 2 wherein the body further comprises a conicaltransition passage interconnecting the tubular body passage portion andthe sealing cylinder passage portion, said sealing plug disposed in saidconical transition passage.
 4. The sealing valve according to claim 1wherein said compressing element comprises a compression piston having apiston passage therein, said piston passage aligned with said plugpassage when said compressing element is urged against said sealingplug.
 5. The sealing valve according to claim 4 wherein said compressingelement further comprises a lever which is pivotally mounted on saidvalve body.
 6. The sealing valve according to claim 1 wherein saidspring comprises a helical compression spring.
 7. The sealing valveaccording to claim 1 wherein said spring comprises a spiral spring. 8.The sealing valve according to claim 5 wherein said spring comprises aleaf spring.
 9. The sealing valve according to claim 5 wherein saidneutralizing element comprises a snap hook which is engageable with saidlever to prevent said spring from urging said compressing element frommoving said plug into sealing engagement with said passage.
 10. Thesealing valve according to claim 8 further including a guide groove forguiding said leaf spring.
 11. The sealing valve according to claim 8wherein said leaf spring further comprises a bent leaf spring portion,said lever including an aperture for engagement with said bent leafspring portion for preventing said spring from urging said compressingelement from moving said plug into sealing engagement with said passage.12. The sealing valve according to claim 11 further including a tappetand a tappet actuating button for causing said vent portion to be movedout of said aperture.